MedPath
FDA Approval

Otezla

September 20, 2023

HUMAN PRESCRIPTION DRUG LABEL

Apremilast(30 mg in 1 1)

Products (3)

Otezla

55513-137

NDA205437

NDA (C73594)

ORAL

July 27, 2023

Code: UP7QBP99PNClass: ACTIBQuantity: 30 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT

Otezla

55513-369

NDA205437

NDA (C73594)

July 27, 2023

Otezla

55513-485

NDA205437

NDA (C73594)

July 27, 2023

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